Official Title: “An Observer-Blind, Randomized, Parallel-Group Study to Compare the Efficacy of Two Rizatriptan Prescribing Portions for the Treatment of Migraine”

The primary objective of this study is to evaluate a clinical limit of rizatriptan (9 rizatriptan 10mg ODT per month) vs. a formulary limit of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study

A common clinical perception exists that less effective treatment of attacks increases the burden of disease across attacks in the form of increased attack frequency, severity, duration, and/or treatability. If this perception is true, more effective treatment decreases the burden of disease across attacks. There are multiple barriers to effective treatment. The triptan class of migraine medications is frequently dispensed in the context of health benefit plan formulary limitations. Because of limited supply, medications must be used very cautiously. Patients may hoard medication in reaction to fear of running out. Overly cautious use and hoarding may lead to greater disease burden.

The purpose of this study is to compare the effect of two allocations of rizatriptan - a more limited allocation ("Formulary Limit") vs. a less limited allocation ("Clinical Limit") on disease burden.

Primary:

• Number of days with migraine each month for 6 months No

Secondary:

• Number of migraine attacks each month for 6 months No
• Responder rate (50% decrease in attack frequency) each month for 6 months No
• Average attack duration each month for 6 months No
• Headache severity of all attacks each month for 6 months No
• Symptom elimination at 2 hours post-dose for all attacks each month for 6 months No
• Functional disability at 2 hours post-dose for all attacks each month for 6 months No
• Adverse experiences 6 months Yes

Inclusion Criteria:

• Patient is at least 18 years of age
• Patient has at least a 1-year history of migraine with or without aura by IHS criteria 1.1 and 1.2
• Patient typically has 3-8 migraine attacks/month
• Patient has less than 10 headache days/month with no evidence of IHS 8.2 Medication
• Overuse Headache
• Patient receives their triptan medication under a pre-determined prescribing allocation ranging from 6-12 tablets per month for the last 3 months preceding Visit 1.
• Patient and investigator agree that multiple doses of rizatriptan described in the package circular are appropriate for non-responsive or recurring headache.
• Patient uses a triptan as mainstay of acute therapy at Visit 1.
• Patient of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of rizatriptan outside the study.
• Patient understands study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

• Patient has headache disorders beyond migraine or episodic tension-type headache IHS 2.1
• Patient is receiving prophylactic therapy for migraine
• Patient is currently taking:
• Daily or nearly daily (typically >3 days out of 7 days) use of non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, or other analgesics. Aspirin less than or equal to 325mg daily is allowed for cardioprotection.
• Monoamine oxidase inhibitors (MAOIs) Propranolol Patient taking either an MAOI ro propranolol may be enrolled in the study, if in the clinical judgement of the investigator, either of these medications can be discontinued 2 weeks prior to study entry. Otherwise the use of MAOIs and propranolol are prohibited during the study.
• Patient has basilar or hemiplegic migraine headache.
• Patient has history or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or finding consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina), or other significant underlying cardiovascular disease.
• Patient has uncontrolled hypertension.
• Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan or any of its inactive ingredients.
• Patient is pregnant or a nursing mother.
• Patient has a history (within 1 year) or current evidence of drug or alcohol abuse.
• Patient has received treatment with an investigational device or compound within 30 days of the study (Visit 1).
• Patient had clinical evidence of significant pulmonary, renal, hepatic, endocrine, neurologic (apart from migraine), psychiatric or any other condition that, in the opinion of the investigator may confound the results of the study, pose an additional risk, or interfere with optimal participation in the study.

Lead Sponsor: Clinvest

San Francisco Clinical Research Center

San Francisco California 94109 United States

Brian Koffman, MD

Diamond Bar California 91765 United States

Physician Associates

Oviedo Florida 32765 United States

Dr. B. Abraham, PC

Snellville Georgia 33039 United States

Dhiren Shah, MD

Prince Frederick Maryland 20678 United States

Westside Family Medical Center

Kalamazoo Michigan 49009 United States

Clinvest

Springfield Missouri 65807 United States

Mercy Health Research / Ryan Headache Center

St. Louis Missouri 63141 United States

PharmQuest

Greensboro North Carolina 27401 United States

Thomas Jefferson University Hospital Jefferson Headache Center

Philadelphia Pennsylvania 19107 United States

Overall Clinical Trial Officials and Contacts

Roger K Cady, MD Principal Investigator Clinvest  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00397254

Study ID Number: 078-00

ClinicalTrials.gov Identifier: NCT00397254

Health Authority: United States: Institutional Review Board